You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ADEC 228th meeting resolutions, 5-6 June 2003

Australian Drug Evaluation Committee

5 June 2003

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 228th (2003/3) meeting of the Australian Drug Evaluation Committee (ADEC) (5-6 June 2003) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

INFLIXIMAB - Remicade
Sterile powder for intravenous infusion, 100mg vials
Schering-Plough Pty Limited
Variation: For the treatment of moderate to severe Crohn's Disease to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have had an inadequate response to conventional therapies. The recommended dose is 5 mg/kg given as a single infusion over 2 hours as an induction regimen at 0, 2, and 6 weeks, followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter. For patients who lose response to 5 mg/kg during maintenance treatment consideration may be given to increasing the maintenance dose to 10 mg/kg.

SERTRALINE HYDROCHLORIDE - Zoloft
Tablets, 50mg, 100mg & 200mg
Pfizer (Australia) Pty Ltd
Variation: For the treatment of social phobia (social anxiety disorder) and the prevention of its relapse.

AMOXYCILLIN (AS TRIHYDRATE)- Amoxycillin BC and Maxamox
Sterile powder for suspension, 500mg/5mL, 125mg/5mL and 250mg/5mL, bottles
Biochemie Australia Pty Ltd
Variation: Treatment of acute otitis media in children 6 months of age and older. The recommended dosage in treatment of acute otitis media is 30mg/kg twice daily.

VALACICLOVIR - Valtrex
Tablets, 250mg, 500mg and 1000mg
GlaxoSmithKline Australia Pty Ltd
Variation: For the reduction of transmission of symptomatic genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with Valtrex, it is recommended that patients with recurrent genital Herpes use safer sex practices (see Precautions). The recommended dosage of valaciclovir for reduction of transmission of genital herpes is 500mg taken once daily by the infected partner, in immunocompetent heterosexual adults discordant for HSV-2 antibody with less than 10 recurrences per year.

GADOBENATE DIMEGLUMINE - MultiHance
Sterile solution for intravenous injection, 0.5M in 5mL, 10mL, 15mL and 20mL vials
Omnicare Clinical Research
New Chemical Entity: MultiHance® is indicated for use in adults for enhancement of magnetic resonance imaging (MRI) of the liver and central nervous system (CNS).

Top of page

GADODIAMIDE - Omniscan
Sterile Aqueous solution for injection, 287mg/mL vials, ampoules, syringes
Amersham Health Pty Limited
Variation: For use in infants and neonates less than 6 months of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity.

STAVUDINE - Zerit XR
Modified release capsules, 37.5mg, 50mg, 75mg and 100mg
Bristol-Myers Squibb Australia Pty Limited
Variation: For the treatment of HIV infected adults in combination with other antiretrovirals.

ALTEPLASE - Actilyse
Sterile powder for intravenous injection, 10mg, 20mg and 50mg vials
Boehringer Ingelheim Pty Ltd
Variation: For the thrombolytic treatment of acute ischaemic stroke. Treatment should only be initiated within 3 hours after the onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging techniques.

ETANERCEPT - Enbrel
Sterile powder for subcutaneous injection, 25mg vials
Wyeth Australia Pty Ltd
Variation: For the treatment of the signs and symptoms of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic therapy has been inadequate. Etanercept is not indicated for the treatment of psoriasis not associated with manifestations of arthritic disease.

Top of page

FENOFIBRATE - Lipidil
67mg and 200mg capsules, 160mg film coated tablets
Laboratories Fournier S.A.
New Chemical Entity: Lipidil™ is indicated for the treatment of the following as an adjunct to diet in the treatment of:

  • hypercholesterolaemia and hypertriglyceridaemia
  • types II, III, IV and V dyslipidaemia
  • dyslipidaemia associated with type II diabetes

INFLIXIMAB - Remicade
Sterile powder for intravenous infusion injection, 100mg vials
Schering-Plough Pty Limited
Variation: For the treatment of Ankylosing Spondylitis: Remicade™ is indicated for the reduction of symptoms and improvement in physical function in patients with active disease.The maintenance therapy should be 5mg/kg by iv infusion every 6 weeks.

METHYL-5-AMINOLEVULINATE (AS HCl) - Metvix
Cream, 160mg/g tube
PhotoCure Australia Pty Ltd
Variation: For the primary treatment of superficial and/or nodular basal cell carcinoma where surgery is considered inappropriate.

LANREOTIDE (AS ACETATE) - Somatuline Autogel
Sterile subcutaneous solution for injection, 60mg, 90mg and 120mg syringe
Ipsen Pty Ltd
Variation: For the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who are dopamine agonist treatment refractory.

EZETIMIBE - (Ezetrol)
Uncoated tablets, 10mg
Merck Sharp & Dohme (Australia) Pty Ltd
Variation: For use either as monotherapy or in conjunction with an HMG-CoA reductase inhibitor (statin), as an adjunct to diet in the treatment of primary hypercholesterolaemia.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee
26 June 2003

Top of page